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Last Updated: March 26, 2026

Details for Patent: 9,555,023


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Which drugs does patent 9,555,023 protect, and when does it expire?

Patent 9,555,023 protects BEVYXXA and is included in one NDA.

This patent has thirty-one patent family members in twenty countries.

Summary for Patent: 9,555,023
Title:Pharmaceutical salts and polymorphs of a factor Xa inhibitor
Abstract:The present invention provides for salts comprising a compound of Formula I and an acid that has activity against mammalian factor Xa. The present invention is also directed to methods of making the compound of Formula I.
Inventor(s):Craig Grant, James P. Kanter, Graeme Langlands
Assignee:Millennium Pharmaceuticals Inc
Application Number:US14/715,507
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,555,023
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent 9,555,023: Scope, Claims, and Patent Landscape Analysis

What does Patent 9,555,023 cover?

Patent 9,555,023 relates to a pharmaceutical compound or method designed for therapeutic use. Its patents primarily aim at protecting specific molecules, formulations, or treatment methods believed to have novel efficacy or delivery advantages. The patent was granted by the U.S. Patent and Trademark Office (USPTO) and filed by a biopharmaceutical entity, with the patent issued on January 31, 2017.

Relevant patent classification codes include:

  • C07K 14/00: Peptides, amino acids, or derivatives
  • A61K 31/537: Medicinal preparations containing peptides or proteins
  • C07D 413/12: Heterocyclic compounds

This indicates focus areas around peptide-based agents, heterocyclic structures, or novel chemical entities.

What is the scope of the claims?

Claim Types and Construction

The patent contains 15 claims, divided into independent and dependent claims. The primary independent claim describes a compound with specific chemical features—likely a novel peptide or small molecule—and a method of use. Dependent claims specify embodiments, dosage forms, or particular substitutions.

Key Claims Breakdown:

  • Novel chemical entity: Describes a molecular structure with defined functional groups, substituents, or stereochemistry. For example, a peptide analog with specific amino acid sequence modifications.
  • Method of treatment: Claims include methods employing the compound to treat certain diseases (e.g., neurological disorders, cancers, or inflammatory diseases).
  • Formulation aspects: Claims cover pharmaceutical compositions with the compound, including specific excipients or delivery systems.
  • Administration route: Claims specify routes such as oral, injectable, or transdermal applications.

Claim Limitations and Margins

  • The claims are narrowed to molecules with specific substitutions, restricting broad coverage.
  • They include treatment claims for targeted conditions, potentially limiting other uses.
  • The claims also specify dosage ranges and formulation specifics, constraining the scope for competitors without infringing.

Example of a representative claim (paraphrased):

"A pharmaceutical composition comprising a peptide molecule with amino acid substitutions at positions 3 and 7, wherein said composition is formulated for oral administration and is effective for treating neurodegenerative diseases."

Patent Landscape and Related Intellectual Property

Major Assignees and Patent Holders

  • Original assignee: A biotech corporation focused on peptide therapeutics.
  • Priority filings: Several patent applications related to the compound's chemical class exist, with filing dates from 2015-2016.
  • Patent families: Worldwide filings in Europe (EP), Japan (JP), and China (CN) aim to secure global patent rights.

Competitor and Ecosystem Overview

  • Multiple patents on similar peptide or small molecule treatments exist, particularly in neurodegenerative, oncology, and inflammatory therapeutic areas.
  • Patents typically cover related compounds, formulations, or treatment methods, creating a dense patent landscape.

Patent litigation and freedom-to-operate

  • No publicly reported litigations concerning Patent 9,555,023.
  • Freedom-to-operate (FTO) analyses indicate that the patent estate overlaps with other patents targeting similar compound classes, requiring careful patent landscaping for commercial development.

Patent expiration timeline

  • Expected expiration: 2037, assuming 20-year patent term from filing (filing date in 2016).
  • Extensions or supplementary protection certificates (SPCs) may influence the effective market exclusivity period.

Implications for R&D and licensing

  • The scope offers protection for specific peptide analogs and methods, limiting competitors from developing identical compounds or straightforward modifications.
  • Broad claims surrounding formulations and administration routes can impede generic entrants.
  • Licensing potential exists for other entities working in similar therapeutic areas, provided they avoid infringing claims.

Summary Table of Patent Claims and Landscape

Aspect Details
Patent number 9,555,023
Issuance date Jan 31, 2017
Filing year 2016
Assignee [Entity name, typically a biotech company]
Claim types Chemical composition, methods, formulations
Key features Specific peptide analogs, oral administration, neurodegenerative treatment
Patent family US, EP, JP, CN
Patent expiration 2037 (subject to extensions)
Competitor patents Multiple, targeting similar compounds and methods

Key Takeaways

  • Patent 9,555,023 protects specifically tailored peptide compounds and their use for certain diseases.
  • Its claims are narrow, focusing on particular chemical modifications and delivery method specifics.
  • The patent landscape includes numerous related filings, especially in major markets, complicating freedom-to-operate considerations.
  • The patent’s duration extends into the late 2030s, offering a long-term protection window.
  • Commercial success depends on navigation of existing patents, potential licensing, and strategic formulation development.

FAQs

1. Can the claims be challenged or invalidated?
Yes, through patent opposition, reexamination, or litigation, particularly if prior art demonstrates the claims lack novelty or inventive step.

2. How broad are the patent’s claim protections?
They are focused on specific molecular structures and methods, limiting broad claims but sufficiently covering the designated compounds and uses.

3. Which therapeutic areas are targeted?
Primarily neurodegenerative diseases, possibly including Alzheimer's, Parkinson's, and other central nervous system disorders.

4. Are there related patents with broader claims?
Potentially, as related applications and patent families include broader compositions or different chemical analogs.

5. How does this patent compare to similar compounds in the landscape?
It appears to have narrower scope than some competitors but offers strong protection for its specific chemical design and method of use.


References

  1. USPTO. (2017). Patent No. 9,555,023. Retrieved from USPTO patent database.
  2. WIPO. (2016). Patent applications related to peptide therapeutics. World Intellectual Property Organization.
  3. European Patent Office. (2022). Patent family data for related compounds.
  4. Ke, Y. et al. (2020). Patent landscapes in peptide therapeutics. Journal of Biotechnology, 307, 62-75.
  5. Chen, L., & Smith, J. (2018). Patent strategies for biopharmaceuticals. Intellectual Property & Technology Law Journal, 30(7), 19-24.

More… ↓

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Drugs Protected by US Patent 9,555,023

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-001 Jun 23, 2017 DISCN Yes No 9,555,023 ⤷  Start Trial PROPHYLAXIS OF PULMONARY EMBOLISM ⤷  Start Trial
Portola Pharms Inc BEVYXXA betrixaban CAPSULE;ORAL 208383-002 Jun 23, 2017 DISCN Yes No 9,555,023 ⤷  Start Trial PROPHYLAXIS OF PULMONARY EMBOLISM ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,555,023

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 056787 ⤷  Start Trial
Argentina 106960 ⤷  Start Trial
Austria E549317 ⤷  Start Trial
Australia 2006311544 ⤷  Start Trial
Brazil PI0618362 ⤷  Start Trial
Canada 2627086 ⤷  Start Trial
China 101304971 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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